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- 2026-05-20 07:16:29
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- Big 5 DC pass HIV treating two-drug regimen Dovato
- by Eo, Yun-Ho Jun 22, 2020 06:08am
- General hospitals in Korea are reviewing the prescription of GlaxoSmithKline’s (GSK) Dovato, a two-drug regimen indicated to treat HIV-1 infection. The pharmaceutical industry sources reported the drug committees (DC) at the Big Five general hospitals like Seoul National University Hospital and Severance Hospital have passed Dovato (dolutegravir/ lamivudine) after it was listed for reimbursement from early June. The healthcare reimbursement is granted for using Dovato in patients with HIV-1 infection with and without AIDS-related symptoms, who tests baseline CD4 cell count below 350/㎟, exceeds viral load of 100,000 copies /㎖, or is acknowledged by an infectious disease specialist to be prescribed with the drug. Moreover, the drug’s reimbursement would be provided for a pregnant person with HIV infection, infant born from HIV-infected mother, healthcare provider exposed to HIV infection, and spouse (partner) of a person with HIV infection for preventive purpose. In Phase III GEMINI1 and GEMINI2 trials, the drug was used to treat adult patients with HIV infection, and they confirmed the drug’s safety and antiviral effect equivalent to other triple-drug regimen (dolutegravir, tenofovir disoproxil fumarate and emtricitabine). And in TANGO trial, adult patients, who maintained viral suppression for at least six months on a tenofovir disoproxil fumarate (TAF)-containing triple-drug regimen, demonstrated a similar level of viral suppression effect after switching to the two-drug regimen. Recommended to administer a single tablet once-daily, 18,528 won per tablet Dovato would cost 555,840 won, monthly. The drug’s pricing is equal to the existing single-drug regimen option Tivicay (dolutegravir), which is at about 72 percent of the triple-drug regimen Triumeq (abacavir/ dolutegravir/ lamivudine).
- Policy
- 26 million flu vaccines will be released this year
- by Lee, Tak-Sun Jun 22, 2020 06:08am
- It is expected that 26 million flu vaccines will be released this year. The MFDS is planning to cooperate closely with the industry in preparation for an increase in demand for inoculation due to the prevalence of COVID-19 and the flu at the same time in the second half of the year. On the 18th, the MFDS announced that it will hold a briefing on the lot release of flu vaccines in 2020 for domestic vaccine manufacturers and importers. The main contents of the briefing are ▲ Amendments to the lot release approval regulations ▲ Precautions when preparing a summary of manufacturing and quality control ▲ Plan for procurement of vaccination for public use. Influenza vaccine planned for domestic distribution in 2020 An official from the MFDS said, "We expect the country's seasonal flu (influenza) vaccine to be approved for the lot release this year at about 26 million. And plans to work closely with the KCDC." The MFDS said that it would pay attention to the condition of COVID-19 ooutbreak, and will promptly approve the lot release so that seasonal flu vaccines can be supplied smoothly, and closely monitor supply and demand in cooperation with the KCDC.
- Company
- Yuyu Pharma exports FDA-approved COVID-19 test kit
- by Lee, Seok-Jun Jun 22, 2020 06:08am
- CEO Yu Wonsang of Yuyu Pharma (left) and CEO Lee Hyo-keun of SD Biosensor In partnership with SD Biosensor, Yuyu Pharma is to export COVID-19 test kit. At SD Biosensor headquarters office in Suwon on June 17, two companies signed a supply deal on real time polymerase chain reaction (RT-PCR) test kit for COVID-19. SD Biosensor’s COVID-19 test kit has received the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) in April. As a result, USD 5.2 million worth of 300,000 kits were supplied to the U.S. Federal Emergency Management Agency (FEMA) as well. The RT-PCR kit, named 'STANDARD M nCoV Real-Time Detection Kit.,' amplifies and detects specific nucleic sequence to diagnose COVID-19 infection through human nasopharyngeal swabs and throat swab samples. SD Biosensor is one of six Korean companies that received EUA from FDA and one of seven companies Korea Centers for Disease Control and Prevention (KCDC) approved EUA for. CEO Yu Wonsang of Yuyu Pharma stated, “Using the company’s global network, the COVID-19 testing kit would prioritize export to the U.S. first and later expand out to other countries.”
- Company
- Outpatient Rx amount for major chronic diseases decreased
- by Chon, Seung-Hyun Jun 22, 2020 06:08am
- Prescriptions for chronic diseases such as hyperlipidemia, hypertension, and diabetes, which have the largest sales due to COVID-19, have been reduced by half. According to UBIST, a drug research agency on the 17th, the outpatient prescription size was ₩2,360 billion in April and May, a 9.0% decrease from the same period last year. In April, the outpatient prescription amount fell 8.7% from the same period last year, and the prescription amount decreased 9.4% last month. Prescriptions for major chronic diseases that form a large market have declined. The prescription amount for statin drugs used in the treatment of dyslipidemia was April and May, at 1618 billion won, a 4.0% decrease from the same period last year. Considering that the prescription amount of statins in April and May rose 7.1% year-on-year, the decline was large. In the first quarter, the outpatient prescription for statin drugs in the first quarter was ₩247 billion, an increase of 3.0% compared to the same period last year, but turned downward from April. The prescription amount for statin drugs in April was ₩82 billion, a 2.8% decrease from the previous year, and decreased by 5.1% in May. The prescription amount for hyperlipidemic drugs in the first quarter was ₩120 billion, up 26.0% from the previous year, but the prescription amount in April and May increased by 15.2%. Recently, Rosuvastatin or Atorvastatin and Ezetimibe combined drugs increased explosively as the preference increased, but growth has been slow since April. Monthly outpatient Rx Amount for major chronic disease treatments (Unit: ₩100 million, Source: UBIST) It is analyzed that a full-scale prescription difference occurred in the second quarter as patients with chronic diseases received long-term prescriptions in advance in February and March when the number of COVID-19 infected patients surged. In fact, when the number of COVID-19 infected patients surged, it was reported that the number of patients receiving prescriptions for 3 to 6 months in advance increased significantly. The large chronic disease prescription market, such as hypertension or diabetes, has a similar pattern. The April/May prescription for 'ARB+CCB' combination, the most commonly used hypertension drug, increased 2.3% compared to the same period last year. Compared to last year's April and May prescriptions, an increase of 7.1% over the previous year, growth has slowed. In the first quarter, the prescription size of outpatients was ₩198 billion, an increase of 10.0% from the same period last year. ‘ARB+CCB' is a combination drug of calcium channel blocker (CCB) and angiotensin II receptor blocker (ARB). The prescription amount of 'ARB+CCB' combination in the first quarter of last year was ₩180 billion, an increase of 9.2% over the previous year. However, the growth rates in April and May were reduced to 3.2% and 1.4%, respectively. In April and May, prescription amount for ARB-based drugs were ₩64.1 billion, a 3.3% decrease from the same period last year. The prescription amount in April and May last year increased by 7.2% from the previous year, but this year it decreased. Prescription amount for ARB-based drugs decreased in April and May by 2.8% and 4.9% YoY, respectively. The size of the April/May prescription for the 'DPP4-inhibitor + Metformin' combination, which is the most widely used diabetes treatment, was ₩30.7 billion, a 1.4% decrease from last April & May (₩30.5 billion). The prescription amount of 'DPP4-inhibitor + Metformin' in the first quarter rose 6.9% from last year. Monthly outpatient Rx amount for major antibiotics (Unit: ₩100 million, Source: UBIST) The amount of antibiotic prescription was significantly reduced in the major prescription market. The prescription amount of Cephalosporins in April and May was ₩29.6 billion, a 39.2% decrease from the same period last year. Prescriptions for oral Cephalosporins fell 1.3% year-on-year, but fell sharply after April. It decreased by 41.2% in April compared to the same period last year, and decreased by 37.1% in May. Prescription amount of oral Penicillins decreased 11.9% in the first quarter compared to the previous year, but fell 57.0% in April and May. It is analyzed that the decrease in antibiotic prescription is closely related to the decrease in the number of patients. This is because after the spread of COVID-19, external activities contracted and personal hygiene management, such as washing hands and wearing a mask, strengthened, and the incidence of infectious diseases such as cold decreased. According to statistics released by UBcare last month, prescriptions for acute nasopharyngitis in April were 71% less than in the same period last year. In April, the amount of prescriptions for children and adolescents decreased by 52% from the previous year, and the number of prescriptions dropped by 76%.
- InterView
- EASY-ON opens up new opportunity to Xarelto amid COVID-19
- by Eo, Yun-Ho Jun 19, 2020 06:24am
- PM Jung Changho COVID-19 has brought dramatic changes to our lives. Witnessing these changes, scholars stress the importance of responding and planning for the prospective changes in the post-coronavirus era. And many pharmaceutical companies are also seeking for new changes in business model amid COVID-19 pandemic. For the pharmaceutical industry, the novel infectious disease has been increasingly limiting the conventional sales activity, which highlighted the importance of non-contact multi-channel marketing. Now the online-based marketing tools are emerging as an answer, and companies are taking the cue to expand various non-contact sales channels like one-on-one detailing service, web symposium and e-catalogue. In March, when COVID-19 was spreading fast in Korea, Bayer Korea launched non-contact detailing service ‘EASY-ON’ and swiftly tackled on the changes in the society’s trend. EASY-ON is an online video consulting solution that provides latest clinical findings and anti-coagulant prescription related medical information for primary healthcare institutes like private clinics to better manage chronic atrial fibrillation. The program has specialized nurse with clinical experience as a consultant to engage with the healthcare providers. .Daily Pharm interviewed Product Manager (PM) Jung Changho, who led the EASY-ON project launch, for the story of the present and future of non-contact sales .Bayer -Please give us a short introduction to yourself for the readers Started as a medical representative in the cardiovascular sector since 2009, I joined the Xarelto sales division in 2016 .Currently, I am in charge of planning and operating the EASY-ON project in the marketing team, and it has been over a year being the PM for Xarelto team .-Marketing and sales around the world are largely obstructed by the COVID-19 pandemic .What kind of changes have you experienced after the outbreak, and how is the Xarelto team responding to the situation ? The non-contact marketing and sales back in the day used to lack the drive .Of course, many pharmaceutical companies have been continuously working on remote multi-channel marketing before, but after the outbreak, the companies are more eager to diversify the communication channels and try them in real life .As the conventional sales are deeply rooted in face-to-face engagement, I was always skeptical of other channels and their effect .But, with the recent incident, I have learned the clients are more ready to accept the new system than how we expected, and that they are more open and positive to review a new communication channel .-Apparently, EASY-ON program launch was planned before the COVID-19 ? Actually, the plan for EASY-ON predates the COVID-19 outbreak—it was initially planned to improve the atrial fibrillation patient management .And the project took the momentum as the outbreak started in the time of the launch .The objective of the EASY-ON is to inform private clinic healthcare providers to adequately manage atrial fibrillation patients, and to fixed imbalanced information caused when using an anticoagulant .Unlike general hospitals, private clinics have contacted the company through various channels to query prescription related information, which shows the information asymmetry between the two .And this is how EASY-ON came about .The ultimate goal of the project is to educate the healthcare providers for patients to truly benefit from treatment options .-How is the program generally operated ? The first and the most important benefit of EASY-ON is having seasoned specialist nurse to give consultation via video conference call .The second benefit is that the program focuses on atrial fibrillation, which tends to require more intricate care and treatment compared to other chronic disease .The healthcare providers can access relevant in-depth information, because EASY-ON specializes in atrial fibrillation and relevant treatment information, .About three months since the launch in March, approximately 200 healthcare providers have joined the program so far .It constantly provides scheduled consulting service to the members .The EASY-ON platform offers overall ten basic learning materials based on basic information of the health condition, which is accessible on demand after the consulting session .-General hospital and private clinic healthcare providers are torn between the prescription options of non-Vitamin K antagonist oral anticoagulants (NOAC) like Xarelto and initial care .Between the two clientele, which does Bayer tries to put more focus on ? Most importantly, no patient should be left behind by any one of them .So both are very important channels we need to take care of .At the moment, general hospitals are encouraging patients to be diagnosed at general hospital and to manage the condition at clinics .And clinics anticipate contributing in the initial anticoagulant treatment in atrial fibrillation patients .Bayer’s biggest mission is to have the patients with atrial fibrillation to receive adequate treatment, regardless of general hospital or clinic, and to manage the condition properly .-Any memorable anecdote with the EASY-ON to share ? A private clinic in a hard to access remote region gave a quite memorable feedback .Despite the needs for the anticoagulant treatment information, the healthcare provider there did not have a good and efficient access to the information .But in the end they expressed gratitude for our EASY-ON program when basic information and key information needed for seeing a patient were provided through a video call platform .-What’s next for EASY-ON ? The project is aiming to secure 2,000 members within this year .Although the service has been reactively responding, the company is preparing a channel to academically engage with general hospital professors in real time for their unmet needs .For the EASY-ON clients, web symposium consisting of specialized consulting webinars would be organized to talk about differences in each clinical trial and solution in each case .And other informative materials like FAQ or newsletter would be disseminated to the EASY-ON members to answer their queries on NOAC .
- Policy
- What is the solution for Remdesivir/generic competitiveness?
- by Lee, Tak-Sun Jun 19, 2020 06:21am
- Kim Young-ok, director of pharmaceutical safety bureau at the MFDS There was no communication between the MFDS and the pharmaceutical industry due to the COVID-19 crisis that began in Korea from the end of January. Since the 'Director of pharmaceutical safety bureau at the MFDS-CEO Meeting in 2020' was postponed indefinitely on February 12, the news of the MFDS was only occasionally available through data and articles. The 'Online Video Conference between the MFDS and the factory managers in the pharmaceutical industry' held on the 2nd and 9th attracted attention as it was a place of communication after a long time. The MFDS says it will continue to expand such non-face-to-face video conferencing and investigation. Officially met with reporters this year, Kim Young-ok, director of pharmaceutical safety bureau at the MFDS, also selected keywords of the MFDS as a solution to non-face-to-face environmental changes and generic competitiveness measures after the COVID-19 outbreak. In addition to the reporter's meeting with director Kim Young-ok held on the 16th, there was also a story about the homework facing the MFDS in COVID-19 crisis. These include, for example, special imports of Remdesivir and clinical trials of COVID-19 treatments. The following is a summary of the meeting with Director Kim Young-ok. After COVID-19 incident, how will the factory survey be conducted? "As the non-face-to-face environment becomes common, it is inevitable to change. Some are already doing so. For example, if there is a due diligence report from the PIC/s member countries, it replaces the actual investigation. I'm going to try a method that I can see even if I don't go, and I think I can connect to the company and employees through video equipment to look at facilities, equipment, etc. Korea has good IT technology and networks, If it goes well, I think these things will be enlarged and become everyday." Will the policy briefing sessions proceed in a non-face-to-face manner in the future? "I recently had a videoconference with the factory manager of a pharmaceutical company, and I plan to expand it in the future because it was a place where I could communicate with the field without face-to-face. There are several technical and unfamiliar parts. There are many effective aspects. The policy briefing session is also looking for ways to make it non-face-to-face, and it is also considering ways to post content on Youtube and so on, so that it does not end in one time. Counseling is also being prepared so that the videoconference can proceed as much as possible." In this non-face-to-face situation, can clinical trials of COVID-19 treatment be conducted properly? "The clinical trials for new drug development should also prepare for system maintenance according to non-face-to-face. Change has already begun.. In the case of COVID-19 treatment, it is difficult for clinical trial operators to contact and even obtain consent. The agency has made improvements to ensure that clinical trials can be carried out smoothly. As a result, 12 clinical trials related to COVID-19 treatment and 2 vaccines have been approved." How is the public-private partnership to strengthen the competitiveness of generic drugs? Paradoxically, international confidence in medical products in Korea has been increasing a lot since COVID-19. I think Korean medicine should enter the global market with this opportunity. It is discussing strengthening international competitiveness of generic drugs through public-private councils in this regard. There are two main objectives. The first is to provide accurate information to the people, and the second is to make 'K-Generic' grow into the future industry. In order for these things to work, we need to help them enter the global market. The MFDS is planning to proceed with international cooperation with local governments so that Korean companies can obtain product approvals quickly from overseas countries. The public-private council plans to announce the final conclusion in late June." How is the cause of NDMA detected in Metformin being investigated? “We plan to draw a final conclusion through the NDMA investigation committee. We are investigating with the manufacturer with the detected item. We went through due diligence to understand the situation. When the data is gathered in the committee, it seems that scientific conclusion will be reached. However, it seems difficult to complete the cause investigation within a short period of time because there are various facts (causes) in the process.” How is the discussion of accident compensation due to the NDMA case going on? "This issue is also being discussed through the public-private council. However, I think we should see the lawsuit result in the Valsartan case. I intend to participate if it goes through legislative assembly with regard to personal contributions." How is the proceedings of special import for Remdesivir going? "We are in the process of discussing with Gilead and the KCDC. The timing and quantity of supply will be decided in a consultation process. Gilead is also actively negotiating. These drugs need to be approached in that respect because the company has more publicity than taking private profits. Gilead knows well." Isn’t the reevaluation of Choline alfoscerate formulations too late? “We are going at our own pace. The schedule of the MFDS was in June, and it seems to be going as it was. In the meantime, there were data limitations, and thus, manufacturers were asked for additional data. Some experts reviewed it internally, and some evaluations were conducted by the evaluation agency. Currently, Pharmaceutical Affairs Review Committee’s meeting is scheduled to be held and it will be asked if a special reevaluation is appropriate. If a special reevaluation is conducted, it is planned to seek advice on how appropriate it is. When the results are announced, we will take steps to organize the position of the MFDS and publish it soon. However, the Committee is not a deliberative body, but an advisory body.”
- Policy
- Lee Nak-yeon, would continue to support COVID-19 development
- by Lee, Jeong-Hwan Jun 19, 2020 06:20am
- 민주당 코로나19 국난극복위원회 이낙연 위원장(왼쪽)과 전혜숙 부위원장Chairman Lee Nak-yeon urged the MOHW and the MFDS to fully compensate for the cost of R&D so that domestic COVID-19 vaccines and therapeutics can contribute to the world. On the 17th, Chairman Lee attended the 'One-Health Strategy Debate on Future Infectious Diseases X' hosted by the Democratic Party of Korea’s COVID-19 National Overcoming Committee. Chairman Lee said that even if domestic COVID-19 vaccines and treatments are not developed for the first time in the world, policy support and cost compensation should be sufficiently provided. In particular, he pointed out that the new infectious diseases, including COVID-19, are caused by the spread of common infectious diseases, and that the 'one-health research system' between the government, industry, and academics should be promptly established. "In recent meetings with pharmaceutical representatives, the development of COVID-19 vaccine is delayed compared to the initial forecast, the more this is done, the sooner the health research system needs to be established." Lee said. Chairman Lee said, “We hope that vaccines and treatments will be made in Korea for the first time in the world, but they have sufficient strategic and industrial value even if they are not the first. It is clear that the message will be supported to the end. The MOHW and the MFDS must fully compensate for the R&D expenses as the President promised." He added, "If the domestic pharmaceutical industry develops a therapeutic drug and makes a profit, it will be reassuring to give it back. We look forward to the day when the Korean pharmaceutical industry will contribute beyond the prevention and diagnosis to the treatment and prevention of humanity."
- Policy
- Dexamethasone would be difficult to use as direct treatment
- by Lee, Jeong-Hwan Jun 19, 2020 06:20am
- While Dexamethasone focused global attention as a candidate for the COVID-19 treatment, the government decided that Dexamethasone would be difficult to use as a direct treatment. The government explained that Dexamethasone, which is considered a relatively old drug, is used to alleviate severe inflammation rather than directly treating COVID-19. On the 17th, at 2 pm, the head of the Central Disease Control Headquarters, Jung Eun-Kyeong, answered the question of using Dexamethasone in a regular briefing question and answer. Dexamethasone is attracting attention as a result of a clinical study published in the UK that significantly lowers the mortality rate of severe patients. However, Jung Eun-Kyeong believes that Dexamethasone would be difficult to use as a fundamental solution to directly treat COVID-19 infection. Head Jung Eun-Kyeong said that Dexamethasone is a steroid-based drug, and although it can be expected to relieve severe inflammation, it is not enough to expect the effect of eliminating the virus itself. In particular, The head hoped that overseas research result for Dexamethasone would not have much effect on the amount of Remdesivir, which is pursuing special import for COVID-19 treatment. She said, "Dexamethasone is a common drug that is used primarily to reduce inflammation. Medical experts have suggested that this drug reduces inflammation, but it also reduces immunity and requires attention. I think it's not a drug that fundamentally treats COVID-19 infection, but an anti-inflammatory drug." She added, "It is necessary to discuss experts such as clinical doctors to determine whether clinical research of Dexamethasone (for direct treatment of COVID-19) is needed. I don't think this medicine will affect other medicines (such as Remdesivir)."
- Company
- “Immunotherapy Tecentriq, a crucial turning point for TNBC"
- by Eo, Yun-Ho Jun 19, 2020 06:20am
- Professor Im Seock-ah “The release of immunotherapy makes a significant difference in treating triple-negative breast cancer with limited treatment options.” To this date, treating the triple-negative breast cancer (TNBC), reacting negatively on all receptors (estrogen, progesterone and HER2), has not been struggling with high unmet medical need. Programmed death-ligand 1 (PD-L1) inhibiting immunotherapy Tecentriq (atezolizumab) is now getting the limelight as it has been newly indicated to treat patients with TNBC. Roche Korea (President Nic Horridge) convened a press conference on June 17 at the Westin Chosun Seoul regarding the shift in TNBC treatment paradigm. On Jan. 30, Korea’s Ministry of Food and Drug Safety (MFDS) approved Tecentriq, in combination with nanoparticle albumin-bound (nab) paclitaxel, to treat patients with PD-L1 positive, unresectable, locally advanced or metastatic TNBC. The indication made Tecentriq to be the first and only immunotherapy to treat patients with TNBC in Korea. In the IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. In the same patient group, the Tecentriq combination therapy marked the median overall survival (mOS) at 25.0 months. Professor Im Seock-ah at the oncology department of Seoul National University Hospital said, “The Tecentriq combination therapy demonstrated a meaningful improvement in PFS and mOS longer than two years in patients with metastatic TNBC. We can anticipate the treatment option to be a crucial turning point in treating metastatic TNBC with high unmet medical needs.”
- Company
- KRPIA-KPBMA welcome MOHW revising stepped pricing reduction
- by Eo, Yun-Ho Jun 18, 2020 06:28am
- “We sincerely welcome the Ministry of Health and Welfare’s reasonable decision.” The pharmaceutical industry, especially the companies preparing an ownership change in drug item, seemed to be relieved with the latest decision by the Korean government. On June 17, Ministry of Health and Welfare (MOHW) preannounced the revised Standard of Pharmaceutical Decision and Adjustment that ultimately exempted stepped drug pricing reduction on transferred drugs. So far, the pharmaceutical industry has been greatly concerned of the government possibly applying stepped drug pricing reduction on the drug products transferred due to corporate restructuring. The controversial Section ‘Ba’ revised The issue of pricing reduction on the transferred drug was first raised when the Standard of Pharmaceutical Decision and Adjustment was revised in February. The Section Ba (바) in the February revision, according to the Pharmaceutical Affairs Act Paragraph 2 of Article 89, stipulates a product transferred by a change in the ownership would be priced at a lower pricing between the final upper limit pricing and calculated pricing. In other words, an item’s pricing could be brought down depending on the number of listed generics and the revised drug pricing conditions the item qualifies for. Pfizer Pharmaceutical Korea (with Pfizer Upjohn Korea) and MSD (with Organon), for instance, are preparing to transfer a number of originals for their split and they were initially expecting significant damage. Also Takeda Pharmaceuticals that recently transferred its antidiabetic pipeline to Celltrion was not completely free from the issue. In case of Pfizer Pharmaceutical Korea transferring Lipitor (atorvastatin) to Pfizer Upjohn Korea, healthcare reimbursement on the first-in-class item would be removed at first. And when the item reapplies for the reimbursement listing, the original would be considered as a generic with over 20 other generics already listed, and Lipitor would be priced at 85 percent of the lowest pricing of other same substance drug. But the newly revised Section Ba stipulates when a same company re-applies for reimbursement listing of an already-listed but removed item, its pricing would be set to a lower pricing either by the final upper limit pricing or by the pricing calculated by the Article 2. Basically, the government newly established a separate regulation to maintain the original pricing of an item transferred to another company due to corporate merger or acquisition. Industry against the February revision, urged the government to revisit the change After the preannouncement of the first revision in February, Korean Research-based Pharmaceutical Industry Association (KRPIA), as well as Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), have conveyed their official statement and urged the government to exclude the items transferred by corporate restructuring from the pricing reduction. KRPIA, representing the global pharmaceutical companies in Korea, has been demanding the government to make an exception in the revised drug pricing system via an authoritative interpretation. The organization claimed the revision did not agree with the initial objective of the regulation to follow the principle of differentiating the drug pricing by recognizing the endeavor to develop a novel drug. KPBMA also supported KRPIA’s argument by demanding the government to assure the status of a first-in-class drug (mostly a novel drug), and by questioning the government’s negative intention to ‘prevent unfair listing of a generic.’ However, the industry’s complain is seemingly subsiding fast as MOHW even set down a separate regulation instead of the demanded authoritative interpretation. KRPIA official said, “The issue could have gravely impacted the novel drug business. We sincerely welcome the government’s decision to prevent making an innocent victim while agreeing with the original objective of the regulation.” KPBMA official also commented, “The decision to sustain the pricing of transferred original drug was appropriate and well reflected the reality of the industry. By exempting the stepped pricing reduction on the transferred item, pharmaceutical companies would feel less burdened when diversifying the business model and collaborating with other partners.”
